Senior TPM QA Associate – Third-Party Manufacturing

Abbott; Fatih; On-site; TRY 500,000 - 800,000; Full time

Job summary

Abbott in Istanbul is seeking a Senior TPM QA Associate to ensure quality and compliance across third party manufacturers within GMP-regulated operations. You will manage deviations, investigations, CAPAs, PQRs, stability programs, and audits, coordinating with internal teams and TPM partners.

The role requires a pharma-related degree and 5–7 years of QA/QC in GMP settings, strong documentation and English skills, and willingness to travel up to 40%.

Qualifications

• Bachelor’s degree in pharmacy, chemistry, chemical engineering or related scientific discipline.
• Minimum 5–7 years in QA/QC and/or pharmaceutical manufacturing in a GMP-regulated environment.
• Good knowledge of cGxP, ICH guidelines and national/international pharma regulations.

Responsibilities

• Accountable for quality and compliance performance of assigned TPMs, ensuring cGMP and QTAs.
• Lead quality risk management activities including deviations, investigations, change controls, CAPAs, PQRs, stability programs, and validation activities.
• Review and approve TPM quality documentation (MRs, Packaging Records, Validation/Reports, Stability Protocols, PQRs, CAPAs).
• Lead quality oversight of TPMs through metrics review, GEMBA visits, remediation plans, and continuous improvement.
• Coordinate audits, supplier qualification, regulatory inspections, tech transfers, and cross-functional projects.
• Provide risk-based recommendations and escalate quality/compliance issues to internal stakeholders and senior management.
• Support QTAs maintenance and Approved Supplier List; align with regional/global quality initiatives.

Skills

Quality Assurance

GxP compliance

ICH guidelines

CAPA management

Deviations & investigations

Validation & qualification

Process validation

Cross-functional collaboration

Report writing

English proficiency

Education

Bachelor’s degree in Pharmacy, Chemistry or Chemical Engineering

Tools

Microsoft Office

Job description

Abbott in Istanbul is seeking a Senior TPM QA Associate to ensure quality and compliance across third party manufacturers within GMP-regulated operations. You will manage deviations, investigations, CAPAs, PQRs, stability programs, and audits, coordinating with internal teams and TPM partners.

The role requires a pharma-related degree and 5–7 years of QA/QC in GMP settings, strong documentation and English skills, and willingness to travel up to 40%.